Kornimate/medical-research-clean huggingface dataset:
methadone monitoring for insights into adverse events

Conditions: Pain; Opiate Addiction

Summary: methadone has been an effective and inexpensive therapy in the management of chronic pain and opioid dependence. however it has been associated with sudden, unexpected deaths. two mechanisms have been suggested, increased drug concentration in the blood, and a change in the heart rhythm. this study will look at blood samples for drug levels and genetic components and ekg's (a noninvasive test which reveals heart rhythm). there will be no intervention.


Eligibility criteria:
inclusion criteria: * must be 18 years of age or older; eligible for methadone treatment as judged by discovery house criteria * must sign informed consent for methadone treatment prior to being approached for this study * must sign a written informed consent for this study * is willing and has a means to return for all scheduled follow-up visits exclusion criteria: * pregnancy, participation in any other clinical trial involving investigational or marketed products with 30 days prior to entry into this study; current use of an inducer/inhibitor of known enzymes involved with methadone metabolism * use of methadone in the 30 days prior to study enrollment; concomitant use of qt prolonging drugs * considered by the treatment physician to be ineligible for methadone treatment; hepatic function panel indicates chronic liver disease.

Keywords: methadone genetic
recrudescence of eating conduct disorders and covid-19

Conditions: Psychiatric Disorder; Eating Disorders in Adolescence; COVID-19

Summary: this qualitative study, combining psychiatric and anthropological perspectives, focused on the development and/or worsening of patients' eating disorders since covid-19, as well as the experiences and perceptions of those around them - such as their family, teachers or staff. school and nursing staff. this multi-site approach will provide a multidimensional perspective on the experience of individuals and those around them, as well as a triangulation of data. the hypotheses to explain the increase in eating disorders (eds) will be addressed through semi-structured interviews offered to study participants.

this study will be offered to all patients treated within the supea of hpncl for tca. the active queue of patients is collected using the hpncl medical software. patients and their parents will be contacted by telephone to inform them and suggest that they participate in this study. the schools will be chosen from those attended by the patients on this list. they will also be contacted by telephone to inform them and suggest that they participate in this study. interviews in the presence of two members of the research team (child psychiatrists, psychologists, anthropologists, etc.) will be offered to all patients. these interviews will be face-to-face when possible, but can also be done remotely, by teleconsultation, depending on the preferences of the participants. these interviews will be based on a questionnaire established beforehand evoking the history of eating disorders and the experience of the participant in the study and his entourage of the covid-19 health crisis. all information exchanged during these interviews will be made anonymous (data collected and processed as well as the results presented). they will be used exclusively in the context of the study and not communicated to the medical team involved in the patient's care. the proposed interviews will be carried out separately with: * the patient presenting or having presented a tca * the parents * one or more health professionals taking care of the patient * the school attended by the patient who will be questioned about the tca and covid-19 problem in general or not about the patient in particular. questionnaires will also be carried out with patients in order to complete the assessment of their clinical condition at a distance from the psychological crisis:

Eligibility criteria:
inclusion criteria: any patient having consulted in the child psychiatric emergency room of the hpncl between november 1, 2021 and november 30, 2021 for suicidal thoughts. age between 13 years and 17 years and 11 months. good understanding of written and oral french. collection of the informed consent of the patient and of one of the two parents or holder of parental authority exclusion criteria: inability to comply with the instructions defined and exposed during inclusion. refusal of participation by the patient or one of the legal guardians
physical activity and bone mineral density in children and adolescents with chronic inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: this study is an observational study. the purpose of this study is to assess the relationship between bone health and daily physical activity in children and adolescents with inflammatory bowel disease (ibd). reduced bone mineral density is a common complication in pediatric ibd. physical activity is an important determinant of health throughout the whole lifespan. engaging in regular moderate-to-vigorous physical activity has important health benefits. based on available evidence, the investigators hypothesize that daily moderate-to-vigorous physical activity could improve bone health (ie bone mineral density) in children and adolescents with ibd.

to carry out this study, 120 patients (age ≥6 and \<18 years at the screening visit) will be enrolled in this observational study. after obtaining the informed consent from the parents and the patient, the followings will be performed: clinical examination by a physician, dual-energy x-ray absorptiometry to assess bone density mineral and body composition, collection of a blood sample to assess the inflammatory status of the ibd patient. the patient will be asked also to fill in a questionnaire in order to assess quality of life. he will wear an accelerometer during 7 consecutive days for assessing daily physical activity in free living conditions. the main objective is to assess the relationship between daily physical activity and bone health in children and adolescents with ibd. the secondary objectives are to assess the relationship between daily physical activity and: 1) body composition and 2): quality of life in ibd children and adolescents. to our knowledge, this study is the first to assess the relationship between bone health and daily physical activity in ibd children and adolescents.

Eligibility criteria:
inclusion criteria: * boys or girls aged between 6 and 18 years old * chronic, acute or intermittent diseas (other than ibd) that can lead to decreased physical activity (example: fracture, paralysis, blindness ... * patient with ibd diagnosed since at least 6 months * written informed consent obtained by the the parents and the patient * to have a health insurance exclusion criteria: * acute intercurrent events (less than 15 days) at the inclusion day leading to decreased physical activity according to the investigator judgment (fracture(s), recent arthritis, perineal lesions, severe skin lesions) * patient refusing to participate to the study * one of the child's parents refusing to participate to the study * lack of adherence foreseeable * participation to another study * pregnant girls * under a justice protect measure

Keywords: physical activity bone health pediatrics bone
pharmacodynamic evaluation of pl2200 versus enteric-coated aspirin in diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: this study will determine if aspirin from pl2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether pl2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes


Eligibility criteria:
inclusion criteria: * non-insulin-dependent diabetes mellitus * adults 21 to 79 years, inclusive * body mass index between 30 and 40 kg/m2, inclusive exclusion criteria: * currently prescribed aspirin or anti-coagulants * contraindications to aspirin * significant disease history or active disease other than non-insulin-dependent diabetes mellitus * patient requires insulin
proximal pole fractures of the scaphoid

Conditions: Proximal Pole Fractures of the Scaphoid

Summary: aim: the aim of this study is to analyze the clinical and radiological outcomes of patients with a proximal pole fracture of the scaphoid primary null hypothesis: there are no factors associated with nonunion of a proximal pole fracture of the scaphoid. secondary null hypothesis: patients with an acute proximal pole fracture of the scaphoid have quickdash (disabilities of the arm, shoulder, and hand) scores at or above the population norm (a score of 13 in the norway and 10.9 in the united states), 2 to 6 months after injury.


Eligibility criteria:
inclusion criteria: * age 18 years or greater * proximal pole fracture of the scaphoid on computed tomography scans made in the planes defined by the long axis of the scaphoid. the proximal pole will be defined as the proximal fifth of the scaphoid, excluding small scapholunate ligament avulsion fractures. * interval between injury and diagnosis of less than 2 weeks. * english or spanish fluency and literacy exclusion criteria: * pregnant women * inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness). * patients with other fractures or injuries
rapid oral test for therapeutic response in hiv/aids patients

Conditions: AIDS/HIV PROBLEM

Summary: this study has been designed to evaluate a new oral test for therapeutic monitoring of hiv/aids patients that are receiving the combination anti-retroviral therapy (cart). the test will measure saliva-based stress response profiling(srp) biomarkers using laboratory assays. results of the test will show if hiv/aids patients successfully responded to cart. preliminary studies showed that srp biomarkers were strongly increased in cart-unresponsive aids patients. however, the diagnostic accuracy of the oral test, patients will be recruited to donate saliva: aids patients responsive or unresponsive to cart, and controls (acute or early hiv patients, and hiv-negative patients with hepatitis). the saliva samples will be used to measure srp biomarker concentrations. results will show whether the biomarker measurements provide accurate and specific diagnostics for art response.


Eligibility criteria:
inclusion criteria: group 1, cart-unresponsive * documented hiv-positive before obtaining aids diagnosis * cart for 18 months or longer * consistent lab tests in previous 3-6 months: \ 5000 hiv rna copies/ml group 2, cart-responsive * documented hiv-positive before obtaining aids diagnosis * cart for 18 months or longer * consistent lab tests in previous 3-6 months: \> or equal to 350 cd4 t cells/mm3, viral load \< or equal to 50 hiv rna copies/ml group 3, acute/early hiv acute hiv: * signs and symptoms of acute retroviral syndrome in a person with either a negative or evolving antibody response (western blot or elisa) in presence of a positive hiv p24gag antigen or hiv-1 proviral dna pcr or positive hiv-1 rna early hiv: * a positive antibody response (western blot or elisa) with a documented negative serological test or plasma hiv-1 rna within the past 12 months or a positive elisa and a negative de-tuned elisa within 30 days of a positive elisa specimen in an untreated person with no clinical or immunological evidence of advanced hiv disease (cd4 count \>200 cells/mm3 or \>14%) group 4, hiv-negative hepatitis-positive * hiv test negative (western blot, elisa or viral load) * positive hepatitis b surface antigen and detectable hepatitis b viral load (hcv b rna), treated or not or positive hepatitis c antibodies and detectable hepatitis c viral load (hcv c rna), treated or not exclusion criteria: * pregnant or lactating women * non-adherent patients * any conditions which will affect saliva production: e.g. sjogren's syndrome or chronic mouth dryness * cytotoxic chemotherapy, interferon treatment, or radiation therapy within the preceding 3 weeks * active alcohol or substance abuse (narcotics or other controlled substances) within 6 months prior to the saliva sampling * significant psychiatric illness that in the opinion of the principle investigator might interfere with making an informed decision * incapable to give informed consent

Keywords: saliva diagnostics hiv aids
effectiveness of a lifestyle intervention, for people with smi who meet metabolic syndrome criteria

Conditions: Metabolic Syndrome

Summary: the aim of this study is to evaluate the effectiveness of a lifestyle intervention, to reduce the risk of metabolic syndrome in patients with serious mental illness who receive treatment with antipsychotic medications. the hypothesis of the study is that: the application of a physical health promotion program in people with serious mental illness, who receive treatment with antipsychotic medications, carried out by a mental health nurse, will decrease the presence of metabolic syndrome and contribute to improve their quality of life.


Eligibility criteria:
inclusion criteria: * diagnostic of serious mental illness. * treatment with antipsychotics. * met at least 3 of the 5 criteria of metabolic syndrome according to the ncep atp iii definition. exclusion criteria: * medical contraindications to exercise * admitted to hospital. * intellectual disability

Keywords: metabolic syndrome lifestyle intervention health promotion mental health nurse serious mental illness
study to investigate the treatment benefit of probiotic lactobacillus crispatus m247 in women undergoing homologous level 2 assisted reproductive technology (art) procedures

Conditions: Fertility Issues

Summary: the present study is aimed to explore the treatment effect from the intake of probiotic lactobacillus crispatus m247 in the improvement of clinical and psychological aspects in women undergoing homologous level 2 art procedures.

the use of assisted reproductive technology (art) has increased dramatically worldwide due to the continuous rise in infertility rates; for these reasons an increasing number of couples undertake the path of art, even though this is difficult journey, with uncertain outcomes and possible medical risks, both physical and psychological. in this study the investigators aim to explore the hypothesis that recreating a favorable vaginotype through the intake of the probiotic lactobacillus crispatus m247 can have a positive effect in achieving pregnancy in cryopreserved cycles as well as a positive relationship between vaginal, endometrial (still unknown), gut and oral microbiota.

Eligibility criteria:
inclusion criteria: * women undergoing homologous level 2 assisted reproductive technology (art) procedures * cryopreserved oocytes * d3 embryos * d5 blastulae * age 18-45 exclusion criteria: * presence of submucous uterine myomas. * uterine malformations.
cerebral effects of pulsed radiofrequency on the lumbar dorsal root ganglion with functional magnetic resonance imaging.

Conditions: Lumbar Radiculopathy; Chronic Disease

Summary: evaluation of central (cerebral) effects of pulsed radiofrequency (prf) on the lumbar drg (dorsal root ganglion), using fmri (functional magnetic resonance imaging ). feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by prf on drg, follow up study 20. total amount of subjects 25.

detect and prove the central effects of prf and show the objective working mechanism. prf is often used technique to alleviate chronic radicular neuropathic pain, although good clinical results are observed the precise (central ) working mechanism is still unknown. this study aims to find the central working mechanism. the investigator postulate the existence of central -cerebral effect of prf on the drg (dorsal root ganglion). if the investigator can detect the effect using fmri and demonstrate the objective unequivocal proof that prf on the drg works than the investigator will be able to promote this technique for further use in the chronic pain states.

Eligibility criteria:
inclusion criteria: * 18-75 y * radicular pain in lumbar region more than 6 weeks, neuropathic exclusion criteria: * coagulopathy * implanted pm or scs device * pregnancy * unwilling to undergo mri * psychiatric disorders

Keywords: fmri prf
cpg 7909 injection in melanoma

Conditions: Carcinoma, Melanoma

Summary: to determine the safety, tolerability and effects of cpg 7909 (the study drug) when given with chemotherapy to patients with melanoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed melanoma that is metastatic. * measurable disease according to the recist criteria. * karnofsky performance status of \> 70. exclusion criteria: * prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than dtic). * suspected or known cns metastases.

Keywords: immunotherapy, skin cancer
role of innate immunity in non-cystic fibrosis bronchiectasis

Conditions: Bronchiectasis

Summary: the purpose of this study is to demonstrate that 1) the secretion of mucins, antimicrobial peptides and toll-like receptors is altered in certain patients with non-cf bronchiectasis, which makes them more susceptible to be infected by potentially pathogenic bacteria (ppb); and 2) the electronic nose is able to detect patterns of specific volatile organic compounds (voc) for patients with non-cf bronchiectasis colonized by ppb.

prospective, observational study, which will include 50 patients with non-cf bronchiectasis who will be followed for a period of 12 months. a follow up control will be performed every three months to all patients, consisting in medical record, lung function tests, blood and serum collection, sputum analysis and culture, and collection of exhaled air for analysis using an electronic nose. these tests will also be repeated whenever the patient has an exacerbation. at the beginning and end of the study, a high resolution chest ct will be performed.

Eligibility criteria:
inclusion criteria: * diagnosis of non- cf bronchiectasis based on at least 1 lobe with bronchial dilatation and compatible clinical symptoms such as cough, sputum production and respiratory infections. * signed informed consent. exclusion criteria: * presence of exacerbation in the last 4 weeks. * antibiotic treatment in the last 4 weeks * use of oral corticosteroids in the last 4 weeks * concomitant terminal illness. * current cigarette smoking * active allergic bronchopulmonary aspergillosis * diagnosis of tuberculosis or active non-tuberculous mycobacterial infection

Keywords: bronchiectasis immunity
genetic, environment and its interaction analysis for cardiovascular autonomic neuropathy

Conditions: Cardiovascular Autonomic Neuropathy

Summary: a large-scale, community-based, cross-sectional study was conducted to explore the extent to which genetic, environment and its interactions associated with cardiovascular autonomic neuropathy (can) in general chinese population. a total of more than 2000 participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). data involved in variables of genetic, environment were collected. every participants was complete dna extracted and genotyped by using single nucleotide polymorphism (snp). cardiovascular autonomic functions were measured by using short-term heart rate variability (hrv) to evaluate the outcome of can. genetic analysis were employed to evaluate genetic variants, environmental risk factors and its interactions for can.

a large-scale, community-based, cross-sectional study was conducted to explore the extent to which genetic, environment and its interactions associated with cardiovascular autonomic neuropathy (can) in general chinese population. a total of more than 2000 participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). data involved in variables of genetic, environment were collected. every participant was complete dna extracted and genotyped by using single nucleotide polymorphism (snp). cardiovascular autonomic functions were measured by using short-term heart rate variability (hrv) to evaluate the outcome of can. genetic analysis were employed to evaluate genetic variants, environmental risk factors and its interactions for can.univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of can.

Eligibility criteria:
inclusion criteria: * survey chinese participants with undiagnosed can aged 30-90 years, were included in this study. exclusion criteria: - some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their ca function. briefly, the exclusion criteria were as follows: 1. history or findings of arrhythmia and hyperthyroidism or hypothyroidism 2. pregnancy or lactation 3. serious hepatic or renal dysfunctions (gfr \< 30 ml/min/1.73m2). of these subjects, complete baseline data were obtained for 2,092 (69.46%) of the participants.

Keywords: genetic environment interaction analysis cardiovascular autonomic neuropathy can
multicenter, non-interventional study, describing patients with inherited retinal disease (ird) in france

Conditions: Inherited Retinal Disease

Summary: genetic diagnostic testing becomes increasingly important for enhancing our understanding of the disease notably the genetics and providing the best care to the patients, and several initiatives seek to gather more data in order to better understand and treat those diseases. within this context, novartis and sensgene/strasbourg university hospitals (hus) want to set up, through a research collaboration, a non-interventional study in france to better understand the epidemiology of irds, particularly the distribution of pathogenic variants in patients. this study aims to serve as a starter study to implement an ird national registry led by sensgene/strasbourg university hospitals (hus). the data collected might also be used to populate global european registries. the primary objective has been defined in a sufficient broad way to address this perspective of registries. as irds can present from birth to late middle age, this study will include both children and adult patients regardless of age, sex, and the type of ird.


Eligibility criteria:
inclusion criteria: * all patients, whatever age or gender, clinically diagnosed with ird or with high suspicion for irds based on clinical examination and functional tests (such as fundus exam and erg), regardless of genetic testing * patients who attended a consultation at one of the participating centers from sensgene network over the inclusion period starting from sites initiation * patients who had been prescribed a genetic test for ird prior to or at the date of inclusion. exclusion criteria: * patients/parents/legally authorized representatives (lar) opposed to the collection and processing of their medical data/the medical data of their children/the medical data of the person for whom they are lar; * patients who are suffering from any other retinal disorder or optic neuropathy that may clinically or genetically overlap with ird or non-genetic (phenocopy); * patients/parents/legally authorized representatives (lar) refusing genetic testing; * patients lacking decision-making capacity: mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation.